Ankle EVAL-ASSIST Portable Technology to Assess Ankle Instability

The DoD as a whole seeks the capability to optimally and rapidly return to duty the high rates of Warfighters with destabilizing lower limb injuries and conditions, the most prevalent injury being acute lateral ankle sprains and chronic ankle instability. Over 70% of the general population experience acute ankle sprains in their life, and the rate of ankle sprains in military personnel is nearly five times greater than that reported in the general public. Given the high prevalence of ankle sprains among DoD and civilian populations, there is a need for effective preventative and rehabilitative options in order to minimize the impact ankle injuries have on wellbeing, mission readiness, and productivity. The largest obstacles to rapid recovery today are inundated medical systems with too few experienced clinicians, the subjectivity of many examinations which limit the efficiency of patient transfers and efficacy of patient recovery tracking, and the limit on ankle injury data that could inform better military and civilian policies and protective equipment.  Lynntech proposes the development of an Ankle EVAL-ASSIST device which, through intelligent sensor fusion, collects objective and clinically useful metrics for mechanical and functional ankle instability, gives high fidelity and reliable data with the ability to determine measurement quality, is easy to use by the layman and does not hinder the wearer or clinician during standard evaluation procedures or ambulation. As is, the device has a clear path to FDA 510(k) approval as a Class I medical device, as a step towards a long-term goal of integrating with ML to develop a reliable and easy to use Class II diagnostic device.